400 adolescents were vaccinated with the first component of the Sputnik M vaccine as part of a clinical investigation

November 23
Healthcare

During the third phase of the Sputnik M vaccine clinical investigation for adolescents, 700 people have already passed a medical examination, 400 of them have been vaccinated for the first time. This was announced by Anastasia Rakova, Deputy Moscow Mayor for Social Development. According to her, the number of sick children in the capital has increased significantly. During incidence peak in October, there were more than a thousand of them every day.

"If earlier pediatric COVID-19, as a rule, proceeded either in an asymptomatic form, or with mild manifestations of acute respiratory viral infections, now we are increasingly fixing a mid or severe form of the disease. Previously, hospitalization of a child was an extremely rare situation, now we are hospitalizing 25 to 30 children with COVID-19 a day — these are already significant figures. This is due to the new strain — it is more aggressive. To date, there are 150 children with coronavirus infection in the hospital, four of them are on artificial lung ventilation devices. All this requires us to apply more serious therapy. Even now, we often use drugs that block the development of a cytokine storm. We have worked out a new algorithm, according to which children from the risk group began to use monoclonal antibodies at an early stage to prevent the severe course of the disease," Anastasia Rakova said.

Three thousand volunteers will take part in the third phase of the investigation of the COVID-19 vaccine safety and effectiveness for adolescents from 12 to 17 years, of which 2.4 thousand people will receive the vaccine, and 600 people will receive a placebo. The distribution of adolescents into one or another group will be carried out randomly using a special method — randomization. Neither teenagers, nor parents, nor a doctor will know which group the teenager will fall into, and will not be able to influence this.

Adolescents who have not previously had a coronavirus infection and have no contraindications can take part in the study. A temporary contraindication may be an ARVI two weeks before the expected date of vaccination or a vaccination against another disease made less than 30 days before participating in the investigation. Those who wish to participate in clinical investigations should send an application by e-mail [email protected] .

The study is conducted on the basis of 12 medical organizations of the City Department of Health: children's city polyclinics № 133, 86, 130, 129, 148, 23, 110, 120, 61, 143, Morozov Children's City Clinical Hospital and Bashlyaeva Children's City Clinical Hospital.

The organizer of the study is the Gamaleya National Research Center for Epidemiology and Microbiology of the Ministry of Health of the Russian Federation.

Participation in the investigation of the coronavirus vaccine effectiveness and safety for adolescents is completely voluntary and is carried out in accordance with all international standards and regulations.

Source: mos.ru

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